Module 12 2019

Validation • With implementation of NeeS standard, in 2008, and mandatory requirements for eSubmission, a project was started to have Validation criteria • Workgroup set-up of Industry and Agency responsible for defining criteria • Between 2008 and 2013, updates have been made: – Updates due to M1 changes – Changes to have 100% clear criteria between tool vendors

The Organisation for Professionals in Regulatory Affairs